StrokeREVISNCT02405143
Restoration of Vision After Stroke
A study testing Active tACS using DC-Stimulator MC in people with Stroke and Infarction; Posterior Cerebral Artery, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Occipital stroke is associated with homonymous visual field defects (occurring on one side of the visual field). Despite spontaneous recovery, some degree of defect is often permanent. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Infarction; Posterior Cerebral Artery, Hemianopsia
- What is being tested?
- Active tACS using DC-Stimulator MC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Occipital ischemic or hemorrhagic stroke 6 months or older
- Hemianopia or quadrantanopia demonstrated by standard automated perimetry
- Visual field defect is stable across baseline
- Presence of residual vision and detectable gradual transition between the the intact and absolutely blind parts of the visual field
- Best corrected visual acuity for at least one eye better or equal to 0.4
Who cannot join
- Eye or central nervous system disease that interferes with the study
- Cardiac pacemaker
- Other metallic devices or implants precluding participation in MRI scans
- Pregnancy or lactation period
- Epileptic seizures in the past 10 years
- Use of antiepileptic or sedative drugs
- Expected low compliance due to substance abuse
- Known active malignancy
Trial locations and contacts
1 site in 1 country.
Turgut Tatlisumak, MD, PhD contact
About this study
Official title: Electrical Stimulation for Restoration of Vision After Stroke in the Damaged Visual Field of Patients With Unilateral Stroke (REVIS Helsinki)
Occipital stroke is associated with homonymous visual field defects (occurring on one side of the visual field). Despite spontaneous recovery, some degree of defect is often permanent. Currently, no treatment exists for such visual field defects.The purpose of this study is to test the efficacy of a type of electrical brain stimulation method, transcranial alternating current stimulation, in reducing these type of visual field defects in their chronic stage.
- Conditions
- Stroke, Infarction; Posterior Cerebral Artery, Hemianopsia
- Being tested
- Active tACS using DC-Stimulator MC, Sham stimulation using DC-Stimulator MC
- Keywords
- Controlled clinical trial, Electric Stimulation Therapy
- Medical subject headings
- Stroke, Infarction, Posterior Cerebral Artery, Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tACS using DC-Stimulator MCDevice
Transcranial alternating current stimulation (tACS) is administered using DC-Stimulator MC (NeuroConn GmbH, Ilmenau Germany). Stimulation is administered through two 5 cm2 saline-soaked electrodes placed in the Fpz position and on the right arm. Stimulation will consist of short blocks, during which stimulation frequency will be ramped up to 30Hz with maximum current of 1.5mA. Stimulation will be administered for 20 minutes on 10 consecutive weekdays.
Sham stimulation using DC-Stimulator MCDevice
Patients in the sham group will undergo the same preparations as the treatment group. This includes using an identical electrode placement and session duration as for the experimental arm. In order to create the effect of phosphenes, one 5Hz current burst per minute will be administered using the individual phosphene threshold of the patient. This is not expected to have therapeutic effects.
| Study group | Role | What they receive |
|---|---|---|
| Active tACS using DC-Stimulator MC | Experimental | 15 to 30 patients will be randomized to the arm receiving the active transcranial alternating current stimulation (tACS) treatment using DC-Stimulator MC. Receives: Device: Active tACS using DC-Stimulator MC |
| Sham stimulation using DC-Stimulator MC | Sham comparator | The same number of patients as in the active arm, 15 to 30, will be randomized to receive sham stimulation using DC-Stimulator MC. Receives: Device: Sham stimulation using DC-Stimulator MC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved detection in the visual field defined as the percentage change of the stimulus detection rate in High-resolution perimetry (HRP)
HRP is a computer-based perimetry using a supra-threshold stimulus. It is used to detect residual vision between the absolute defect and seeing field and to monitor subtle changes in perceptual ability. HRP is performed in fixation control using an eye tracker.
The primary outcome measure will be the percentage change in HRP detection accuracy between pre-test and post-test measurements.
Measured: Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment
Secondary outcomes (1)
The change in extent of visual fields in standard automated perimetry
A secondary outcome measure will be the change in extent of visual fields i.e. mean threshold measured by means of standard automated perimetry.
Measured: Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Finland
- Responsible party
- Principal investigator, Turgut Tatlisumak, MD, PhD, FAHA, FESO, Helsinki University Central Hospital
- Investigators
- Turgut Tatlisumak, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405143
- Sponsor's protocol ID
- UAK1010001
- Acronym
- REVIS
- Status last verified
- Mar 2015
- First submitted
- 6 Feb 2015
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation for Restoration of Vision After Stroke in the Damaged Visual Field of Patients With Unilateral Stroke (REVIS Helsinki)
- ClinicalTrials.gov ID
- NCT02405143
- Acronym / sponsor ID
- REVIS / UAK1010001
- Conditions
- Stroke, Infarction; Posterior Cerebral Artery, Hemianopsia
- Keywords
- Controlled clinical trial, Electric Stimulation Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Academy of Finland
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Occipital stroke is associated with homonymous visual field defects (occurring on one side of the visual field). Despite spontaneous recovery, some degree of defect is often permanent. Currently, no treatment exists for such visual field defects.The purpose of this study is to test the efficacy of a type of electrical brain stimulation method, transcranial alternating current stimulation, in reducing these type of visual field defects in their chronic stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tACS using DC-Stimulator MC | Experimental | Device: Active tACS using DC-Stimulator MC15 to 30 patients will be randomized to the arm receiving the active transcranial alternating current stimulation (tACS) treatment using DC-Stimulator MC. |
| Sham stimulation using DC-Stimulator MC | Sham comparator | Device: Sham stimulation using DC-Stimulator MCThe same number of patients as in the active arm, 15 to 30, will be randomized to receive sham stimulation using DC-Stimulator MC. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Occipital ischemic or hemorrhagic stroke 6 months or older
- Hemianopia or quadrantanopia demonstrated by standard automated perimetry
- Visual field defect is stable across baseline
- Presence of residual vision and detectable gradual transition between the the intact and absolutely blind parts of the visual field
- Best corrected visual acuity for at least one eye better or equal to 0.4
Key exclusion criteria (8 listed)
- Eye or central nervous system disease that interferes with the study
- Cardiac pacemaker
- Other metallic devices or implants precluding participation in MRI scans
- Pregnancy or lactation period
- Epileptic seizures in the past 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tACS using DC-Stimulator MCTranscranial alternating current stimulation (tACS) is administered using DC-Stimulator MC (NeuroConn GmbH, Ilmenau Germany). Stimulation is administered through two 5 cm2 saline-soaked electrodes placed in the Fpz position and on the right arm. Stimulation will consist of short blocks, during which stimulation frequency will be ramped up to 30Hz with maximum current of 1.5mA. Stimulation will be administered for 20 minutes on 10 consecutive weekdays. | Device | Active tACS using DC-Stimulator MC |
| Sham stimulation using DC-Stimulator MCPatients in the sham group will undergo the same preparations as the treatment group. This includes using an identical electrode placement and session duration as for the experimental arm. In order to create the effect of phosphenes, one 5Hz current burst per minute will be administered using the individual phosphene threshold of the patient. This is not expected to have therapeutic effects. | Device | Sham stimulation using DC-Stimulator MC |
Primary outcome
Improved detection in the visual field defined as the percentage change of the stimulus detection rate in High-resolution perimetry (HRP)
Time frame: Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment
HRP is a computer-based perimetry using a supra-threshold stimulus. It is used to detect residual vision between the absolute defect and seeing field and to monitor subtle changes in perceptual ability. HRP is performed in fixation control using an eye tracker. The primary outcome measure will be the percentage change in HRP detection accuracy between pre-test and post-test measurements.
1 secondary outcome
The change in extent of visual fields in standard automated perimetry
Time frame: Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Turgut Tatlisumak, MD, PhD contact
Turgut Tatlisumak, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tACS using DC-Stimulator MC in people with Stroke and Infarction; Posterior Cerebral Artery, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Turgut Tatlisumak, MD, PhD (turgut.tatlisumak@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved detection in the visual field defined as the percentage change of the stimulus detection rate in High-resolution perimetry (HRP) (time frame: Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.